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U.S. Food and Drug Administration
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  3. Dietary Supplements
  4. Information on Select Dietary Supplement Ingredients and Other Substances
  5. Methylsynephrine in Dietary Supplements
  1. Information on Select Dietary Supplement Ingredients and Other Substances

Methylsynephrine in Dietary Supplements

Methylsynephrine is a substance that does not meet the statutory definition of a dietary ingredient. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Methylsynephrine does not fit under any of these categories, rendering misbranded any dietary supplement products that declare methylsynephrine as a dietary ingredient.

Methylsynephrine is also known as:

  • oxilofrine
  • p-hydroxyephedrine

For More Information: 

This webpage describes FDA’s views and recent actions with regard to an ingredient used in products marketed as dietary supplements.  If you have evidence that calls FDA’s views into question, we invite you to submit it, along with your reasoning, to FDA at ODSP@fda.hhs.gov.

This page is not intended to provide a complete list of all FDA actions and communications with regard to this ingredient and its use in products marketed as dietary supplements.

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